SYNERGY MEGATRONRecalls & reported problems across all models
Boston Scientific Corporation · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 146
- Deaths reported
- 11
- Injuries reported
- 45
- Recalls
- 0
We found 28 models of SYNERGY MEGATRON by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 146 adverse event reports in the FDA's MAUDE database, received between Mar 15, 2021 and Jun 16, 2026 — classified as 11 deaths, 45 injuries, 90 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (55 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SYNERGY MEGATRON problems
Device problems
- Difficult to Remove55
- Break42
- Adverse Event Without Identified Device or Use Problem27
- Failure to Deflate12
- Material Rupture12
- Material Deformation11
- Material Integrity Problem11
- Device Dislodged or Dislocated10
Patient problems
- No Clinical Signs, Symptoms or Conditions117
- Angina7
- Restenosis7
- Myocardial Infarction5
- Dyspnea4
- Foreign Body In Patient4
- Obstruction/Occlusion4
- Thrombosis/Thrombus4
SYNERGY MEGATRON models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SYNERGY MEGATRON™ H7493942832350Coronary drug-eluting stent3 deaths17 reports
- SYNERGY MEGATRON™ H7493942816500Coronary drug-eluting stent14 reports
- SYNERGY MEGATRON™ H7493942812500Coronary drug-eluting stent11 reports
- SYNERGY MEGATRON™ H7493942820500Coronary drug-eluting stent9 reports
- SYNERGY MEGATRON™ H7493942816350Coronary drug-eluting stent1 death8 reports
- SYNERGY MEGATRON™ H7493942820350Coronary drug-eluting stent1 death8 reports
- SYNERGY MEGATRON™ H7493942820400Coronary drug-eluting stent1 death7 reports
- SYNERGY MEGATRON™ H7493942824500Coronary drug-eluting stent7 reports
- SYNERGY MEGATRON™ H7493942832400Coronary drug-eluting stent1 death7 reports
- SYNERGY MEGATRON™ H7493942832450Coronary drug-eluting stent7 reports
- SYNERGY MEGATRON™ H7493942812450Coronary drug-eluting stent6 reports
- SYNERGY MEGATRON™ H7493942832500Coronary drug-eluting stent6 reports
- SYNERGY MEGATRON™ H7493942816400Coronary drug-eluting stent1 death5 reports
- SYNERGY MEGATRON™ H7493942816450Coronary drug-eluting stent5 reports
- SYNERGY MEGATRON™ H7493942808500Coronary drug-eluting stent1 death4 reports
- SYNERGY MEGATRON™ H7493942828350Coronary drug-eluting stent4 reports
- SYNERGY MEGATRON™ H7493942812350Coronary drug-eluting stent3 reports
- SYNERGY MEGATRON™ H7493942824350Coronary drug-eluting stent3 reports
- SYNERGY MEGATRON™ H7493942824400Coronary drug-eluting stent1 death3 reports
- SYNERGY MEGATRON™ H7493942828500Coronary drug-eluting stent3 reports
- SYNERGY MEGATRON™ H7493942820450Coronary drug-eluting stent2 reports
- SYNERGY MEGATRON™ H7493942808350Coronary drug-eluting stent1 report
- SYNERGY MEGATRON™ H7493942808400Coronary drug-eluting stent1 report
- SYNERGY MEGATRON™ H7493942808450Coronary drug-eluting stent1 report
- SYNERGY MEGATRON™ H7493942812400Coronary drug-eluting stent1 report
- SYNERGY MEGATRON™ H7493942824450Coronary drug-eluting stent1 report
- SYNERGY MEGATRON™ H7493942828400Coronary drug-eluting stent1 death1 report
- SYNERGY MEGATRON™ H7493942828450Coronary drug-eluting stent1 report
Recent SYNERGY MEGATRON adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 16, 2026Break; Difficult to Remove
IT WAS REPORTED THAT REMOVAL DIFFICULTY AND SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS CORONARY ARTERY. AFTER PRE DILATION OF THE LESION, A 5.00 X 20MM SYNERGY MEGATRON? DRUG-ELUTING STENT WAS DEPLOYED. DURING WITHDRAWAL OF THE BALLOON CATHETER, IT WAS OBSERVED THAT THE BALLOON WOULD NOT EXIT THE STENT. INFLATION OF THE BALLOON TO 8 ATM WAS PERFORMED, AFTER WHICH DEFLATION AND ANOTHER ATTEMPT TO WITHDRAW WERE MADE. THE BALLOON STILL COULD NOT BE REMOVED FROM THE STENT INTO A NON-BOSTON SCIENTIFIC GUIDE CATHETER. ADDITIONAL INFLATIONS WERE PERFORMED TWO OR THREE MORE TIMES TO REMOVE ALL CONTRAST FROM THE BALLOON. PARTIAL WITHDRAWAL WAS THEN ACHIEVED, AND THE BALLOON WAS ADVANCED APPROXIMATELY HALFWAY INTO THE GUIDE CATHETER, HOWEVER; THE STENT SHAFT FRACTURED WITHIN THE GUIDE CATHETER. SNARING WAS USED TO REMOVE ALL THE FRAGMENTS AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAS FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25520936 ↗MalfunctionMay 4, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 4.50 X 28MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT FELL OFF FROM THE BALLOON. THE DEVICE WAS REPLACED WITH ANOTHER AGENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071208 ↗MalfunctionApr 28, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY CALCIFIED VESSEL. A 4.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE INFLATION FOR STENT EXPANSION AT SUB NOMINAL PRESSURE, THE STENT BALLOON BURST. THE DEVICE WAS REMOVED AND THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE STENT WAS RE-PREPPED, AND THE RUPTURED STENT BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE STENT OF SIMILAR DIAMETER AND LENGTH. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25023712 ↗InjuryApr 28, 2026Fracture
IT WAS REPORTED VIA USER MEDWATCH MW5184787 THAT STENT FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 5.00 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. THE STENT WAS ADVANCED THROUGH THE VESSEL; HOWEVER, WHEN PULLING OUT THE STENT, IT BROKE IN THE VESSEL. A SNARE DEVICE WAS USED TO SUCCESSFULLY RETRIEVE THE DETACHED SEGMENT. NO PATIENT COMPLICATIONS WERE REPORTED. NOT FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25015212 ↗MalfunctionApr 18, 2026Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A VERY TORTUOUS ILIAC ARTERY. A 3.50 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. HOWEVER, WHEN THE STENT WAS LOADED ONTO THE UNKNOWN GUIDEWIRE AND ADVANCED TO THE NON-BOSTON SCIENTIFIC (BSC) GUIDELINER CATHETER, THE STENT SHAFT SNAPPED. THE DEVICE WAS THEN REMOVED FROM THE NON-BSC GUIDEWIRE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919435 ↗MalfunctionMar 30, 2026Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. FOLLOWING NORMAL PREPARATION, A 5.00 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER THE STENT BALLOON WAS INFLATED AT NOMINAL PRESSURE, THE BALLOON WAS DEFLATED; HOWEVER, IT GOT STUCK WITHIN THE STENT AND HAD TO PULL HARD TO GET THE BALLOON OUT. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE AND PULL THE DEVICE, BUT THE BALLOON REMAINED STUCK IN THE STENT. ADDITIONAL FORCE WAS APPLIED AND THE GUIDE CATHETER WAS PULLED OUT ALONG WITH THE BALLOON. A NEW GUIDE CATHETER AND AN ALTERNATE DEVICE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED. THE STENT WAS SUCCESSFULLY DEPLOYED, AND THE BALLOON DEFLATED SLOWLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24731803 ↗InjuryMar 30, 2026Break; Failure to Deflate
IT WAS REPORTED THAT DEVICE ISSUES OCCURRED REQUIRING ADDITIONAL INTERVENTION.THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND HEAVILY CALCIFIED RIGHT CORONARY ARTERY. AFTER PLACEMENT OF TWO GUIDE CATHETERS AND TWO GUIDEWIRES, PRE-DILATATION WAS PERFORMED USING MULTIPLE BALLOONS. A 5.00 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) WAS INTRODUCED BUT AFTER THE STENT WAS IMPLANTED, DEFLATION ISSUES OCCURRED, MULTIPLE NEGATIVE DEFLATIONS WERE PERFORMED, HOWEVER, WHEN REMOVING THE CATHETER FROM THE STENT, THE CATHETER BROKE OFF INSIDE THE PATIENT AND HAD TO BE RETRIEVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715424 ↗InjuryMar 24, 2026Material Rupture; Failure to Unfold or Unwrap; Device Dislodged or Dislocated
IT WAS REPORTED VIS MEDSUN (b)(4) THAT BALLOON RUPTURE OCCURRED REQUIRING ADDITIONAL SURGERY.THE PATIENT PRESENTED FOR A RIGHT HEART PERCUTANEOUS, PATENT DUCTUS ARTERIOSUS, STENTING PROCEDURE. THE 5.00 X 16MM SYNERGY MEGATRON WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT DELIVERY SYSTEM BALLOON RUPTURED RESULTING IN A LACK OF DEPLOYMENT OF THE STENT. THE STENT REMAINED IM THE LEFT SUBCLAVIAN ARTERY. THE PATIENT BECAME SEVERELY CYANOTIC AND WAS EMERGENTLY TRANSFERRED TO THE OPERATING ROOM FOR LIFE SAVING INTERVENTION. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF THE RETAINED STENT AND FOR VASCULAR REP.
Patient problems: Hypoxia
MAUDE report 24675410 ↗InjuryMar 3, 2026
THE PT WAS ADMITTED TO HOSPITAL CARDIAC CATH LAB FOR A RIGHT HEART PERCUTANEOUS PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED WITH RESULTING LACK OF DEPLOYMENT OF THE STENT, WHICH REMAINED IN THE LEFT SUBCLAVIAN ARTERY. THE PT BECAME SEVERELY CYANOTIC AND WAS EMERGENTLY TRANSFERRED TO THE OPERATING ROOM FOR LIFE SAVING INTERVENTION. PT BROUGHT BACK TO OR ON [REDACTED] FOR REMOVAL OF THE RETAINED STENT AND VASCULAR REPAIR.
Patient problems: Cyanosis
MAUDE report 24495652 ↗MalfunctionFeb 16, 2026Material Deformation
IT WAS REPORTED THAT SHAFT HOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 26 ENCORE INFLATOR DEVICE WAS INSERTED. A 4.00 X 16MM SYNERGY MEGATRON? DRUG-ELUTING STENT WAS ADVANCED AND ATTEMPTED TO INFLATE BUT NO PRESSURE WAS ACHIEVED BY THE INFLATOR DEVICE. THE STENT WAS SUBSEQUENTLY REMOVED. HOWEVER, UPON INFLATION OUTSIDE THE PATIENT, A DISTAL SHAFT HOLE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY MEGATRON DES. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT HAS FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24344775 ↗MalfunctionDec 9, 2025Entrapment of Device; Nonstandard Device; Detachment of Device or Device Component; Entrapment of Device; Nonstandard Device; Detachment of Device or Device Component
IT WAS REPORTED THAT DEVICE ENTRAPMENT AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 5.00 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT AND DEPLOYED WITHOUT DIFFICULTY. DURING WITHDRAWAL, AS THE BALLOON WAS PULLED BACK INTO THE GUIDE, IT BECAME STUCK IN THE DISTAL GUIDE. AS THE PHYSICIAN BEGAN TO PULL THE DEVICE OUT, THE BALLOON WAS SEPARATED FROM THE DELIVERY SHAFT, REMAINING IN THE GUIDE CATHETER. A TRAPPING BALLOON WAS USED TO SECURE THE DISLODGED BALLOON IN THE GUIDE CATHETER, AND THE GUIDE CATHETER WAS SUCCESSFULLY REMOVED ALONG WITH THE DISLODGED BALLOON. THERE WERE NO PATIENT COMPLICATIONS WHILE REMOVING THE DISLODGE BALLOON AND THE CASE WAS COMPLETED WITH SUCCESS. PATIENT WAS FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DEFLATED PRIOR TO THE INITIAL ATTEMPT TO WITHDRAW THE DEVICE WAS ABOUT 2-3 SECONDS AND WAS FULLY DEPLOYED/EXPANDED DURING STENT DEPLOYMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759223 ↗MalfunctionDec 1, 2025Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED OSTIAL CIRCUMFLEX ARTERY. A 3.50 X 12MM SYNERGY MEGATRON? DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT WAS BENT AND THE INTERNAL LUMEN WAS FRACTURED, RESULTING IN CONTRAST LEAKAGE UPON INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER MEGATRON 3.5 16 MM DES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23678005 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ANGINA AND IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2024, IN-STENT RESTENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH A 4.00 X 24 MM SYNERGY MEGATRON EVEROLIMUS-ELUTING STENT. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF RECURRENT ANGINA. AT THE TIME OF EVENT THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL, WHICH WERE CONTINUED. THE PATIENT WAS DIAGNOSED WITH CORONARY ARTERY DISEASE. CORONARY ANGIOGRAPHY REVEALED A 70% IN-STENT RESTENOSIS AT THE PROXIMAL RCA. A 70% IN STENT RESTENOSIS AT PROXIMAL RCA EXTENDING TO MID RCA DUE TO NEO INTIMAL HYPERPLASIA WAS NOTED AND WAS INITIALLY TREATED WITH A CUTTING BALLOON AND FURTHER SUCCESSFULLY TREATED WITH AN NC BALLOON AND BRACHYTHERAPY. POST REVASCULARIZATION, THE RESIDUAL STENOSIS WAS NOTED AS 30% WITH TIMI FLOW 3. THE EVENT WAS CONSIDERED AS RECOVERED/RESOLVED.
Patient problems: Angina; Restenosis
MAUDE report 23586223 ↗MalfunctionNov 17, 2025Material Rupture; Failure to Unfold or Unwrap; Material Rupture; Failure to Unfold or Unwrap
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.00 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT BALLOON RUPTURED, PREVENTING SUCCESSFUL DEPLOYMENT OF THE STENT. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23568631 ↗MalfunctionNov 4, 2025Nonstandard Device; Difficult to Remove; Failure to Deflate; Nonstandard Device; Difficult to Remove; Failure to Deflate
IT WAS REPORTED THAT BALLOON DEFLATION ISSUE AND REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESIONS WERE LOCATED IN THE CIRCUMFLEX (CX) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES. A 3.50 X 32 MM SYNERGY MEGATRON? DRUG-ELUTING STENT (DES) WAS DEPLOYED IN THE CX ARTERY. FOLLOWING DEPLOYMENT, THE BALLOON FAILED TO DEFLATE AND WAS DIFFICULT TO REMOVE. THE PHYSICIAN ATTEMPTED TO APPLY ADDITIONAL NEGATIVE PRESSURE, BUT THIS WAS UNSUCCESSFUL. THE DEVICE HAD TO BE FORCIBLY WITHDRAWN, AND THE DISTAL END OF THE BALLOON REMAINED INFLATED. THE PHYSICIAN THEN PROCEEDED TO DEPLOY A STENT IN THE DISTAL LAD, FOLLOWED BY PLACEMENT OF A 4.50 X 24 MM SYNERGY? XD DES IN THE PROXIMAL LAD. DURING REMOVAL, SIMILAR DIFFICULTIES WERE ENCOUNTERED. THE DEVICE WAS REMOVED WITH FORCE, AND THE GUIDEWIRE WAS INADVERTENTLY EXTRACTED ALONG WITH IT. ONCE OUTSIDE THE BODY, THE PHYSICIAN HAD TO PULL THE GUIDEWIRE FROM THE BALLOON CATHETER WITH FORCE. UPON INSPECTION, THE PROXIMAL PORTION OF THE STENT BALLOON WAS STILL INFLATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED. IT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23469217 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page